Boston Scientific recalls certain Captivator Polypectomy Snare devices due to potential inability to cut and remove polyps, which may cause prolonged procedures, tissue damage, or bleeding. Affected units have specific lot numbers and expiration dates.
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
Boston Scientific is recalling certain Captivator Polypectomy Snare devices because they may not cut or remove polyps properly. This could lead to longer procedures, tissue damage, bleeding, or the need for surgery. The recall affects specific lot numbers and expiration dates.
The snare may not cut or remove polyps effectively, leading to longer procedures, tissue damage, bleeding, or the need for surgery. While severe injuries are possible, they are rare and have not been reported.
Patients undergoing endoscopic procedures who use the recalled Captivator Polypectomy Snare devices are affected. Medical professionals using the devices for polyp removal are at risk if they have the recalled lot numbers.
Check the outer package UPN number (M00562321) and inner package UPN number (M00562320) on the device. The affected units have specific lot numbers: 25158564, 25245733, 25245735, 25330549, 25403001, 25439073, 25513671, and expire between February 4, 2023 and May 14, 2023.
Look for the lot numbers on the device: 25158564, 25245733, 25245735, 25330549, 25403001, 25439073, or 25513671.
The affected devices expire between February 4, 2023 and May 14, 2023.
The risk is that the device may not cut or remove polyps properly, which could lead to longer procedures, tissue damage, bleeding, or the need for surgery. Severe injuries are rare and have not been reported.
Check the outer package UPN number (M00562321) and inner package UPN number (M00562320). Affected devices have specific lot numbers: 25158564, 25245733, 25245735, 25330549, 25403001, 25439073, or 25513671, and expire between February 4, 2023 and May 14, 2023.
No, the recall does not require immediate discontinuation. The devices are safe for use if they are not the recalled lot numbers and expire after May 14, 2023.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2761-2020 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2761-2020 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
